Document 5DkeGk7pjyg05XpJnbdj8Dmo5

-164 NTER-OFFICE MEMO E H N E C 0 CHEMICALS, INC. MMl- .13745 To M. Freifeld at Piscataway dAte July 5, 1973 From Subject W. C. Champion at Flemington SHIN-ETSU RESINS - FDA STATUS copy to H. B. Carr'----Dr. R. T. Gottc-smai C. W. Johnston H. Landfield R. S. Miller The use of chemical UG as a "short stop" in the Shin-Etsu-process resins will make FDA acceptability of these resins questionable if the chemical is retained on the resin. Chemical UG has FDA sanction for the following uses: 121.2514 121.2520 121.2574 121.2579 121.2585 Resinous and Polymeric Coatings: Phenolic resins only Component of Adhesives \ Polycarbonate Resins: Reactive component 4,4' Isopropylidenephenolepichlorchydrin resins: Reactive component 4,4' Isopropylidenephenolepichlorohydrin Thermosetting Epoxy Resins: Reactive component Only 121.2520, "Components of Adhesives," would permit use in PVC, and this paragraph allows only limited direct contact with food. There is no FDA listing which would support use of chemical UG in packaging film, sheet or bottles. In light of this, three approaches are available: 1. Petition FDA for use of chemical UG under paragraph 121.2566 "Antioxidants and/or Stabilizers for Polymers. 2. Utilize an ingredient such as butylated hydroxy toluene, (Ionol. CP), which already has a listing under 121.2566. 3. Satisfy ourselves that no residual chemical UG is present in the resin, and therefore would not become Ta food additive. In this case, a petition to FDA would not be required. * We would propose that approach,#3 be pursued, since it is probable that no free chemical UG would be present In the finished resin under the conditions of use prescribed by Shin-Etsu. wcc/ ecd IU, c. ti W. C. Champion COLORXTE 013954